alberto repossini, thierry a folliguet

A Multicenter Propensity-score Analysis Of 991 Patients With

Severe Aortic Stenosis And Intermediate-high Risk Profile: Conventional Surgery versus

SuturelessValves versus TAVRClaudio Muneretto, Ottavio Alfieri, Michele De Bonis,

Roberto Di Bartolomeo, Gianluigi Bisleri, Carlo Savini, Gianluca Folesani, Lorenzo Di

Bacco, Manfredo Rambaldini, Juan Pablo Maureira, FrancoisLaborde, Maurizio Tespili,

Alberto Repossini, Thierry A Folliguet

Universityof Brescia MedicalSchool,, Italy, San Raffaele University Hospital, Italy,Universityof Bologna, Italy,Azienda Ospedaliera Carlo Poma, Italy, CHU de Nancy,

France, InstitutMutualiste Montsouris, France, Ospedale Bolognini di Seriate, Italy, CentreHospital-UniversitaireBrabois ILCV, France

Background Surgery(SVR) is still the gold standard in

the treatment of severe aortic stenosis

TAVR has proved as an effective alternative in inoperable or high risk patients.

Recent trend to extend the use of TAVR in patients with intermediate risk profile

Sutureless valve recently become a valuable tool to reduce invasiveness, aortic cross-clamp and CPB time

DivisionofCardiacSurgery–Universityof Brescia MedicalSchool

STS/ACC TVT Registry

AVR

AVR

AVR

AVR

Study population255 Consecutive patientswith severe aortic valve stenosis

PERCEVAL(Group 2)

53 patients

AVR(Group 1)

55 patients

TAVR(Group 3)

55 patients

163matchedPatients

991 intermediate-high risk patients with severe aortic valve stenoses

conventional surgery vs sutureless valve vs TAVR8 European centers

1:1:1propensity score matching

Study Design

Post-Match population612

intermediate-high risk patients

Group 1:Surgical AVR

204 pts

Group 3:TAVR

204 pts

Group 2:Sutureless

valve204 pts


Post-Match populationAVR

(204 pts)

n (%)

Sutureless(204pts)

n (%)

TAVR(204 pts)

n (%)

p-value

AGE (yrs) 80±3 79±4 80±2 0.07EF 54,7±5,1 55,1±7,3 54,6±6,8 0.1EuroSCORE I log 19,2±7,4 18,9±5,9 19,5±6,7 0.34STS score 8,3±4,4 7,9±3,2 8,2±4,2 0.2BMI 26,8±3,2 27,1±2,8 26,9±5,3 0.52FEMALE GENDER 98 (48%) 105 (51,4%) 91 (44,6%) 0.08HYPERTENSION 135 (66,1%%) 138 (67,6%) 129 (63,2%) 0.35DYSLIPIDEMIA 48 (23,5%) 45 (22%) 51 (25%) 0.56COPD 54 (26,4%) 49 (24%) 56 (27,4%) 0.53PREVIOUS PCI 19 (9,3%) 24 (12%) 27 (13,2%) 0,32PREVIOUS AMI 17 (8,5%) 12 (6%) 15 (7,5%) 0.22CAD 49 (24,0%) 42 (20,6%) 53 (25,9%) 0.18CVA 22 (10,7%) 25 (12,2%) 28 (13,6%) 0.65PAD 46 (22,6%) 40 (19,6%) 43 (21%) 0.7DIABETES 54 (26,4%) 57 (28%) 62 (30,3%) 0.11NYHA III-IV 125 (61,2%) 130 (64%) 137 (67,1%) 0.14CRF 37 (18,1%) 31 (15,2%) 44 (21,6%) 0.09REDO 25 (12,2%) 16 (7,8%) 30 (14,7%) 0.056

DivisionofCardiacSurgery – Universityof Brescia MedicalSchool

All-cause 30 days mortality Overall survival at 24 months

Primary Endpoints

Composite Endpoint (MACCE) according to VARC criteria including AR ≥ Grade II at 24 months

Secondary Endpoints

Preoperative Ao Gradient/Area (ECHO)

Division of Cardiac Surgery – University of Brescia Medical School

P=0.01

Peak Gra-dient

Mean Gradient

0102030405060708090

AVRSuture-lessTAVR

mmHgP=NS

AVR Sutureless TAVR0

0.2

0.4

0.6

0.8

Ao Valve Areacm2

P=NS

INTRA-OPERATIVE DATA

DivisionofCardiacSurgery – Universityof Brescia MedicalSchool

p<0.001

p<0.001

CPB CROSS-CLAMP0

20

40

60

80

AVR SUTURELESS

AVR SUTURELESS TAVR19212325

Prostheses Size (mm)p<0.001

POST-OPERATIVE Gradient/AR

AVR PERCEVAL TAVR0

5

10

15

20

25

post-op PEAK GRADIENT (mmHg)p=0,01

AVR PERCEVAL TAVI 0

5

10

15

20

25

post-op MEAN GRADIENT (mmHg)

p=NS

AVR PERCEVAL TAVR0%1%2%3%4%5%6%7%8%9%

10%

AR ≥Grade II

p=0,028

p<0.001

IN-HOSPITAL OUTCOME

BLEED

ING

TRANSF

USION

ACUTE R

ENAL F

AILURE

CVVH

STROKE

VASCULA

R COMPLIC

PM IM

PLANTA

TION

HOSPITA

L MORTA

LITY

0

10

20

30

40

50

60

AVR SUTURELESS TAVR

p<0.001

p=0.005

p<0.001

p=0.008

p=0.007

MACCE AT F-UP (VARC)

0%1%2%3%4%5%6%7%8%9%

10%

AVR Sutureless TAVR

p=0.028

p<0.001

p=0.055

p<0.001TAVR vs SUTURELESS

TAVR vs AVR p<0.001

OverallSurvival

FREE

DOM

FRO

M M

ACCE

(inc

ludi

ng A

R ≥

2)


CoxRegressionAnalysisOverallSurvival

(HR: 2.5; CI 1.1-4.2)

Conclusions


Patients with severe aortic stenosis and intermediate risk profile undergoing TAVR showed a significant worse outcome when compared with conventional surgery and sutureless valve

At the multivariate analysis TAVR was identified as an independent predictor of death (HR 2.5)

The deliberate use of TAVR in this specific subset of patients shoud be restricted in further, independent CRTsTAVR

Thanks

Participating Centers Universityof Brescia MedicalSchool, Italy,

San Raffaele University Hospital, Milan, Italy,

Universityof Bologna, Italy,

Azienda Ospedaliera Carlo Poma, Mantova, Italy,

CHU Nancy, France,

InstitutMutualiste Montsouris, Paris, France,

Ospedale Bolognini Seriate, Italy,

Centre Hospital-UniversitaireBrabois ILCV, Vandoeuvreles Nancy, France

All-cause30-days mortality

All-cause 1-year mortality

All-causedeath

Stroke or TIA

All–causedeath and Stroke or TIA

9985 conventional AVR patients (with or withoutassociated

CABG) and 3875 TAVI patients (TransVascular/TransApical)

Surgical AVR hasoptimalresults in everyriskcategory

TV TAVI TA TAVIAVR

without CABG

AVR with CABG

AGE > 75 86.3% 84.0% 33.3% 44.9%Meanlogistic EURO Score 25.9% 24.5% 8.8% 11%

• Incidence of post-operative complicationhigher in TAVI group

• Higherincidence of paravalvularleak, in particular in TAVI

transvalvulargroup

• TAVR may be an alternative only in high riskpatients with

contraindications for surgery


EARLY POST-OPERATIVEAVR SUTURELESS TAVR P-VALUE

BLEEDING REQUIRING REVISION 6 (3%) 10 (4,8%) 0 (0%) 0.008

ANAEMIA REQUIRING AT LEAST 2 UNITS OF RBC 116 (57%) 73 (35,7%) 67 (32,8%) <0.001

ACUTE RENAL FAILURE 30 (14,7%) 11 (5,3%) 24 (11,7%) 0.007

CVVH 7 (3,4%) 3 (1,5%) 12 (5,8%) 0.06

STROKE6 (2,9%) 4 (1,9%) 7 (3,4%) 0.6

PERIPHERAL VASCULAR COMPLICATIONS 0 (0%) 0 (0%) 20 (9,8%) <0.001

PM IMPLANTATION 8 (3,9%) 20 (9,8%) 30 (14.7%) <0.001

HOSPITAL MORTALITY 7 (3,4%) 12 (5,8%) 20 (9.8%) 0.005

alberto repossini, thierry a folliguet

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